BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3980986 · Received July 24, 2014

    Report

    Report Number
    8020893-2014-01805
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE DEVICE WAS FOUND TO HAVE AN OPEN COMPRESSOR CIRCUIT BREAKER. THE CSE RESET THE COMPRESSOR CIRCUIT BREAKER TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST (SST), EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TESTING ACCORDING TO MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT AN 840 VENTILATOR WENT INOPERABLE WHILE IN USE ON A PATIENT. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE AT TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434871 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1